Jaafer Golzar1, Yoshimitsu Soga2, Anvar Babaev3, Osamu Iida4, Daizo Kawasaki5, William Bachinsky6, James Park7, Jeffery T Prem8, Frank Vermassen9, Juan Diaz-Cartelle10, Stefan Müller-Hülsbeck11, William A Gray12. 1. Advocate Medical Group, Chicago, IL, USA. 2. Kokura Memorial Hospital, Kitakyushu, Japan. 3. New York University Medical Center, New York, NY, USA. 4. Kansai Rosai Hospital, Amagasaki, Japan. 5. Morinomiya Hospital, Osaka, Japan. 6. PinnacleHealth Cardiovascular Institute, Wormleysburg, PA, USA. 7. Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA. 8. Aultman Hospital, North Canton, OH, USA. 9. Ghent University Hospital, Gent, Belgium. 10. Boston Scientific, Marlborough, MA, USA. 11. Ev. Luth. Diakonissenanstalt Flensburg, Germany. 12. Lankenau Heart Institute, Wynnewood, PA, USA.
Abstract
Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy (ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.
Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy (ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.